The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.

The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac Jr sensor is indicated for use in pediatric patients ≥ 12 years of age.

The Acumen IQ sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.

The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.

Device Description

The FloTrac, Acumen IQ, and VolumeView sensors are constructed from two disposable pressure transducers that convert a physiological signal (or mechanical pressure) to an electrical signal that is transmitted through the cable to the patient monitor. The sensors have a straight, flow-through design in which fluid is passed directly across the pressure sensor. The sensors are comprised of a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A polycarbonate housing with an integral stopcock at one end, and an integral flush device at the other end, encloses the sensors.

AI/ML Overview

The provided FDA 510(k) summary for the FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the typical format requested for an AI/ML-based medical device.

This document describes a substantial equivalence determination for extravascular blood pressure transducers (sensors) manufactured by Edwards Lifesciences, LLC. The core of the submission is that the subject devices are identical to the predicate devices in terms of intended use, indications for use, and technological characteristics, EXCEPT for changed pressure tubing and IV set component materials.

Therefore, the "study" described here is primarily focused on demonstrating that these material changes do not introduce new safety or effectiveness concerns, rather than validating an AI/ML algorithm's diagnostic performance against established ground truth.

Here's a breakdown based on the provided text, addressing your questions where possible, and noting where the information is not applicable or not present:

Overview of the Device and Study's Focus:

The devices in question are FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors, which are intravascular pressure monitoring devices that also work with Edwards' arterial pressure-based cardiac output monitoring hardware. The 510(k) submission (K242909) is for modifications to these existing devices, specifically changes to the pressure tubing and IV set component materials. The premise of the submission is that these material changes do not alter the fundamental performance or safety in a way that would require new clinical performance studies typical for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states:

"All testing met the existing predetermined acceptance criteria."
"Based on the performance testing and the technological characteristics, the FloTrac sensors, Acumen IQ sensors, and VolumeView sensors meet the established performance criteria and are substantially equivalent to the predicate."

However, the specific quantitative acceptance criteria (e.g., accuracy +/- X mmHg, drift < Y%, etc.) and the reported numerical performance data from these tests are not provided in this summary document. The summary indicates that "Performance verification was performed in accordance with Edwards' current design requirements," and "shelf-life and sterilization validations have been performed to existing specifications." These are standard engineering and manufacturing performance metrics, not AI/ML performance metrics.

Acceptance Criteria (Quantitative examples are not provided in this document)	Reported Device Performance (General Statement)
Implicit Criteria: Performance equivalent to predicate devices despite material changes; Biocompatibility, Pressure Accuracy, Shelf-life, Sterilization.	"All testing met the existing predetermined acceptance criteria."
"The differences do not raise any new concerns of safety and effectiveness."	"The provided risk analysis and performance verification testing demonstrates the subject devices are substantially equivalent to the predicates."

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "Performance verification" and "Biocompatibility testing." These generally involve lab-based testing (e.g., mechanical stress tests, pressure accuracy checks on a test bench, chemical compatibility tests) rather than patient data test sets in the context of an AI/ML algorithm.

Sample Size for Test Set: Not specified. The nature of the "test set" here refers to physical product samples for engineering verification and manufacturing quality, not a dataset of patient measurements for AI validation.
Data Provenance: The studies mentioned (biocompatibility, performance verification, shelf-life, sterilization) are likely conducted in a controlled lab/manufacturing environment, not directly on patient data. Therefore, questions of "country of origin" or "retrospective/prospective" data collection are not applicable in the context of this type of submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Given this is not an AI/ML submission related to diagnostic imaging or interpretation, the concept of "experts establishing ground truth" in the clinical sense is not applicable. The ground truth for this device's performance would be established through:

Engineering specifications and testing standards for pressure transducers.
Biocompatibility standards (e.g., ISO 10993-1).
Sterilization validation protocols.
Comparison to the performance of the predicate device.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for diagnostic interpretations where multiple readers assess cases. This submission is about the physical device's material change and its impact on manufacturing and engineering performance, not clinical interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is designed to assess the impact of an AI algorithm on human reader performance for tasks like diagnosis or detection. Since this submission is for material changes to a physical sensor, and there is no AI component described, an MRMC study was not performed and is not relevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question pertains to AI/ML algorithms. The device described (pressure sensor) does not have a standalone AI algorithm that would produce a diagnostic output. Its function is to convert a physiological signal to an electrical signal for a monitor.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

Engineering specifications and validated testing methods: For pressure accuracy, electrical signal output fidelity, and physical integrity.
International standards (e.g., ISO 10993-1): For biocompatibility.
Defined shelf-life and sterilization parameters: Within established industry and regulatory norms.
Comparison to the performance characteristics of the legally marketed predicate devices.

This is not ground truth derived from expert consensus, pathology, or outcomes data in the clinical sense, as it's not a diagnostic AI device.

8. The Sample Size for the Training Set

Not Applicable. Training sets are relevant for machine learning algorithms. This submission does not describe an AI/ML component or the training of such a component.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there's no mention of an AI/ML training set, the establishment of ground truth for it is irrelevant to this 510(k) summary.

In summary: This FDA 510(k) summary provides a high-level overview of a submission for material changes to existing medical devices (intravascular pressure sensors). The document focuses on demonstrating substantial equivalence by confirming that these material changes do not negatively impact the device's established performance, biocompatibility, shelf-life, or sterilization. It does not contain the detailed information typically associated with the validation of an AI/ML diagnostic algorithm, such as specific performance metrics, test set sizes for clinical data, expert panel ground truth adjudication, or MRMC study results.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 21, 2025

Edwards Lifesciences, LLC Aeree Lee Sr Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K242909

Trade/Device Name: FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors Regulation Number: 21 CFR 870.2850 Regulation Name: Extravascular blood pressure transducer Regulatory Class: Class II Product Code: DRS Dated: February 21, 2025 Received: February 21, 2025

Dear Aeree Lee:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

{2}------------------------------------------------

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Robert T. for Kazmierski -S LCDR Stephen Browning Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K242909

Device Name

FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

× | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

FloTrac sensors, Acumen IQ sensors, and VolumeView sensors
510(k) Submitter	Edwards Lifesciences, LLCOne Edwards WayIrvine, CA 92614
Contact Person	Primary Contact	Secondary Contact
	Aeree Lee	Karen O'Leary
	Sr. Manager, Regulatory Affairs	Sr. Director, Regulatory Affairs
	Edwards Lifesciences LLC	Edwards Lifesciences LLC
	One Edwards Way,	One Edwards Way,
	Irvine, CA USA, 92614	Irvine, CA USA, 92614
	Tel.: (949) 250-5155	Tel.: (949) 250-0715
	Email: aeree_lee@edwards.com	Email: karen_oleary@edwards.com
Date Prepared	February 21, 2025
Trade Name	FloTrac sensor
	FloTrac Jr sensor
	Acumen IQ sensor
	VolumeView sensor
RegulationNumber / Name	21 CFR §870.2850 / Extravascular blood pressure transducer
Product Code	DRS
Regulation Class	Class II
Predicate Devices	FloTrac, Acumen IQ, and VolumeView sensosr: K152980 (cleared January 19, 2016)
	FloTrac Jr sensor: K231248 (cleared September 21, 2023)
DeviceDescription	The FloTrac, Acumen IQ, and VolumeView sensors are constructed from twodisposable pressure transducers that convert a physiological signal (ormechanical pressure) to an electrical signal that is transmitted through the cableto the patient monitor. The sensors have a straight, flow-through design inwhich fluid is passed directly across the pressure sensor. The sensors arecomprised of a pressure sensitive silicon chip with two electrodes for excitationvoltage and two electrodes for signal output. A polycarbonate housing with anintegral stopcock at one end, and an integral flush device at the other end, encloses the sensors.
	Indications forUse	The FloTrac sensor is indicated for use in intravascular pressure monitoring. Itis also indicated for use with the Edwards arterial pressure based cardiac outputmonitoring devices or hardware to measure cardiac output. They are intended tobe used in adult patients.
		The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring.It is also indicated for use with the Edwards arterial pressure based cardiacoutput monitoring devices or hardware to measure cardiac output. The FloTracJr sensor is indicated for use in pediatric patients ≥ 12 years of age.
		FloTrac sensors, Acumen IQ sensors, and VolumeView sensors	The Acumen IQ sensor is indicated for use in intravascular pressure monitoring.It is also indicated for use with the Edwards arterial pressure based cardiacoutput monitoring devices or hardware to measure cardiac output. They areintended to be used in adult patients.The VolumeView sensor is indicated for use in intravascular pressuremonitoring. It is also indicated for use with the Edwards arterial pressure basedcardiac output monitoring devices or hardware to measure cardiac output.
		ComparativeAnalysis	The subject devices are identical to the predicate devices in terms of theintended use, indications for use, and technological characteristics, except forthe changed pressure tubing and IV set component materials. The differencesdo not raise any new concerns of safety and effectiveness. The provided riskanalysis and performance verification testing demonstrates the subject devicesare substantially equivalent to the predicates.
		Device Testing	Biocompatibility testing was performed in accordance with ISO 10993-1: 2018– Biological evaluation of medical devices – Part 1: Evaluation and testingwithin a risk management process, and FDA guidance document, Use ofInternational Standard ISO 10993-1, "Biological evaluation of medical devices– Part 1: Evaluation and testing within a risk management process", issued onSeptember 4, 2020.Performance verification was performed in accordance with Edwards' currentdesign requirements. In addition, shelf-life and sterilization validations havebeen performed to existing specifications.All testing met the existing predetermined acceptance criteria.
		Conclusion	Based on the performance testing and the technological characteristics, theFloTrac sensors, Acumen IQ sensors, and VolumeView sensors meet theestablished performance criteria and are substantially equivalent to thepredicate.

510(K) SUMMARY

{5}------------------------------------------------

Regulation Number and Section

§ 870.2850 Extravascular blood pressure transducer.

(a)
Identification. An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.(b)
Classification. Class II (performance standards).